Methods of determining the concentration of an analyte in a fluid test sample
First Claim
1. A method of determining the concentration of an analyte in a fluid test sample comprising:
- providing an electrochemical sensor adapted to measure the analyte in the fluid test sample, the electrochemical sensor having a counter electrode and a working electrode;
sufficiently covering the counter and working electrodes of the electrochemical sensor with the fluid test sample;
applying a first potential between the counter electrode and working electrode for a first predetermined time period;
measuring the current between the counter electrode and working electrode at a plurality of intervals during the first predetermined time period;
recording the times of the at least one measurement during the first predetermined time period;
removing or substantially reducing the first potential between the counter electrode and working electrode for a second predetermined time period;
applying a second potential between the counter electrode and working electrode for a third predetermined time period;
measuring the current between the counter electrode and working electrode at least once during the third predetermined time period;
determining the concentration of the analyte in the fluid test sample as a function of the current measured;
calculating an index using at least two of the following;
a measured current and recorded time of the first predetermined time period, and the measured current of the third predetermined time period;
comparing the index to at least one predetermined parameter related to the determined concentration of analyte in the fluid test sample to identify when a bias, if any, exceeds a predetermined threshold; and
displaying either an error signal or an analyte concentration depending on the comparison between the index and the at least one of the predetermined parameter.
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Abstract
A method of determining the concentration of an analyte in a fluid test sample that includes providing an electrochemical sensor adapted to measure the analyte in the test sample. The test sample sufficiently covers a counter and working electrode of the electrochemical sensor. A first potential is applied between the counter and working electrodes for a first predetermined time period and the current is measured and the time is recorded. After the first potential is removed or substantially reduced, a second potential is applied between the counter and working electrodes and the current is measured. The concentration of the analyte is determined in the test sample as a function of the current measured. An index is calculated and compared to at least one predetermined parameter to identify when a bias, if any, exceeds a threshold. An error signal or analyte concentration is displayed depending on the comparison.
197 Citations
36 Claims
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1. A method of determining the concentration of an analyte in a fluid test sample comprising:
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providing an electrochemical sensor adapted to measure the analyte in the fluid test sample, the electrochemical sensor having a counter electrode and a working electrode;
sufficiently covering the counter and working electrodes of the electrochemical sensor with the fluid test sample;
applying a first potential between the counter electrode and working electrode for a first predetermined time period;
measuring the current between the counter electrode and working electrode at a plurality of intervals during the first predetermined time period;
recording the times of the at least one measurement during the first predetermined time period;
removing or substantially reducing the first potential between the counter electrode and working electrode for a second predetermined time period;
applying a second potential between the counter electrode and working electrode for a third predetermined time period;
measuring the current between the counter electrode and working electrode at least once during the third predetermined time period;
determining the concentration of the analyte in the fluid test sample as a function of the current measured;
calculating an index using at least two of the following;
a measured current and recorded time of the first predetermined time period, and the measured current of the third predetermined time period;
comparing the index to at least one predetermined parameter related to the determined concentration of analyte in the fluid test sample to identify when a bias, if any, exceeds a predetermined threshold; and
displaying either an error signal or an analyte concentration depending on the comparison between the index and the at least one of the predetermined parameter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A method of determining the concentration of an analyte in a fluid test sample comprising:
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providing an electrochemical sensor adapted to measure the analyte in the fluid test sample, the electrochemical sensor having a counter electrode and a working electrode;
sufficiently covering the counter and working electrodes of the electrochemical sensor with the fluid test sample;
applying a first potential between the counter electrode and working electrode for a first predetermined time period;
measuring the current between the counter electrode and working electrode at a plurality of times once during the first predetermined time period;
recording the times of the at least one measurement during the first predetermined time period;
removing or substantially reducing the first potential between the counter electrode and working electrode for a second predetermined time period;
applying a second potential between the counter electrode and working electrode for a third predetermined time period;
measuring the current between the counter electrode and working electrode at least once during the third predetermined time period;
determining the concentration of the analyte in the fluid test sample as a function of the current measured;
calculating an index (I) by solving the equation;
I=(Irt/Ibmax)*Tbmax where Irt=a selected measurement of the current during the third predetermined time period, Ibmax=the highest current measured during the first predetermined time period, and Tbmax=the time of the highest measured current is measured during the first predetermined time period;
comparing the index to at least one predetermined parameter related to the determined concentration of analyte in the fluid test sample to identify when a bias, if any, exceeds a predetermined threshold; and
displaying either an error signal or an analyte concentration depending on the comparison between the index and the at least one of the predetermined parameter. - View Dependent Claims (24, 25, 26)
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27. A method of determining the concentration of an analyte in a fluid test sample comprising:
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providing an electrochemical sensor adapted to measure the analyte in the fluid test sample, the electrochemical sensor having a counter electrode and a working electrode;
sufficiently covering the counter and working electrodes of the electrochemical sensor with the fluid test sample;
applying a first potential between the counter electrode and working electrode for a first predetermined time period;
measuring the current between the counter electrode and working electrode at a plurality of times during the first predetermined time period;
recording the times of the at least one measurement during the first predetermined time period;
removing or substantially reducing the first potential between the counter electrode and working electrode for a second predetermined time period;
applying a second potential between the counter electrode and working electrode for a third predetermined time period;
measuring the current between the counter electrode and working electrode at least once during the third predetermined time period;
determining the concentration of the analyte in the fluid test sample as a function of the current measured;
calculating an index using a measured current and recorded time of the first predetermined time period, and the measured current of the third predetermined time period;
comparing the index to at least one predetermined parameter related to the determined concentration of analyte in the fluid test sample to identify when a bias, if any, exceeds a predetermined threshold; and
displaying either an error signal or an analyte concentration depending on the comparison between the index and the at least one of the predetermined parameter. - View Dependent Claims (28, 29)
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30. A method of determining the concentration of an analyte in a fluid test sample comprising:
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providing an electrochemical sensor adapted to measure the analyte in the fluid test sample, the electrochemical sensor having a counter electrode and a working electrode;
sufficiently covering the counter and working electrodes of the electrochemical sensor with the fluid test sample;
applying a potential between the counter electrode and working electrode for a predetermined time period;
measuring the current between the counter electrode and working electrode at a plurality of intervals during the predetermined time period;
recording the time of the plurality of measurements during the predetermined time period;
determining the concentration of the analyte in the fluid test sample as a function of the current measured;
calculating an index using at least one selected measured current and recorded time of the predetermined time period;
comparing the index to at least one predetermined parameter related to the determined analyte concentration in the fluid test sample to identify when a bias, if any, exceeds a predetermined threshold; and
displaying either an error signal or an analyte concentration depending on the comparison between the index and the at least one of the predetermined parameter. - View Dependent Claims (31, 32, 33, 34, 35, 36)
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Specification